MalnutritionNCT03882944
An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
An observational study of Malnutrition, run by Abbott Nutrition at 17 sites in Spain.
Trial summary
This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 310 participants
- Where
- 17 sitesSpain
- Study dates
- 20 Feb 2020to 18 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will include older men and women who are free living (outpatient) or residing in a nursing home, who meet all enrollment criteria. Subjects will be recruited by the investigator(s) from each study site.
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
- Subject is considered malnourished, or is at risk for malnutrition
- Subject conforms to the requirements set forth on the study product label.
- Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation).
- Subject has been elected for hip fracture surgery and is within three days since surgery.
- The study physician determines the subject is fit to participate.
- Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
- After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay < 15 days.
Who cannot join
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
- Subject has active cancer and the study physician determines the subject is not suitable for the study.
- Subject has uncontrolled diabetes.
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
- Participation in another study that has not been approved as a concomitant study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital de Alcorcón
Alcorcón, 28922
Complejo Asistencial de Avila
Ávila, 50003
Hospital Cruz Roja Gijón
Gijón, 33202
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital Infanta Elena
Huelva, 21080
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, 35010
Complejo Asistencial Universitario de León
León, 24071
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Virgen del Puerto
Plasencia, 10600
Hospital Universitario De Salamanca
Salamanca, 37007
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
About this study
Official title: A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status
Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition
Measured: Baseline to Week 12
Secondary outcomes (4)
Barthel Index of Activities of Daily Living
Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction
Measured: Baseline to Week 12
Functional Ambulation Classification Scale (FAC)
6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation
Measured: Baseline to Week 12
Short Physical Performance Battery (SPPB)
Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction
Measured: Week 12
Compliance with Nutritional Supplement
Subject completed consumption dairy
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Feb 2020
- Primary completion15 Dec 2021
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Camprubi, PhD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882944
- Sponsor's protocol ID
- DA20
- Status last verified
- Jun 2022
- First submitted
- 6 Mar 2019
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population
- ClinicalTrials.gov ID
- NCT03882944
- Acronym / sponsor ID
- DA20
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will include older men and women who are free living (outpatient) or residing in a nursing home, who meet all enrollment criteria. Subjects will be recruited by the investigator(s) from each study site.
Key inclusion criteria (8 listed)
- Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
- Subject is considered malnourished, or is at risk for malnutrition
- Subject conforms to the requirements set forth on the study product label.
- Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation).
- Subject has been elected for hip fracture surgery and is within three days since surgery.
Key exclusion criteria (5 listed)
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
- Subject has active cancer and the study physician determines the subject is not suitable for the study.
- Subject has uncontrolled diabetes.
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
- Participation in another study that has not been approved as a concomitant study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional Status
Time frame: Baseline to Week 12
Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition
4 secondary outcomes
Barthel Index of Activities of Daily Living
Time frame: Baseline to Week 12
Functional Ambulation Classification Scale (FAC)
Time frame: Baseline to Week 12
Short Physical Performance Battery (SPPB)
Time frame: Week 12
Compliance with Nutritional Supplement
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Camprubi, PhD study chair
Abbott
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Abbott Nutrition at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Status (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.